Recall Z-0992-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0992-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-30

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-06-30, terminated 2018-04-13. It names one FDA 510(k) clearance: K131684. Product: DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty. Reason: Product may contain the presence of melted sterile packaging upon opening..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Terminated: 2018-04-13
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K131684 — BIOLOX(R) DELTA CERAMIC HEADSBiomet, Inc.·cleared 2013-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty

Reason for recall

Product may contain the presence of melted sterile packaging upon opening.

Data sourced from openFDA. This site is unofficial and independent of the FDA.